Times of India
14 May 2010
By Rema Nagarajan
For the first time in the country, patient groups have won the right, as interested parties, to challenge the patent granted for a medicine.
Delhi Network of Positive People (DNP+), a support group of HIV/AIDS patients, had challenged the patent given to Roche for a drug based on several grounds including that the drug lacked novelty, inventive step and that, being a new form of an old drug, it did not satisfy the requirement of increased therapeutic efficacy as required under section 3(d) of the Indian patent law. The Indian Patent Office at Chennai set aside the patent granted to Roche demonstrating the effectiveness of public health safeguards such as section 3(d) in the Indian patent laws. Roche MD Girish Telang declined to comment on the development when contacted by TOI.
In its decision, the patent office acknowledged that DNP+ was an affected or injured person and had the standing to challenge granted patents. Loon Gangte of DNP+ said, ‘‘The Chennai patent office has set a good precedent. Finally, it has been recognized that patients who are adversely affected by the high prices of medicines have the right to challenge granted patents.’’
The patent office had granted the patent for the drug Valganciclovir to Roche in 2007. Valganciclovir is primarily used as treatment and for prevention of an infection caused by cytomegalovirus (CMV) in organ transplant patients. It is also used to treat cytomegalovirus retinitis, an infection that HIV positive people are susceptible to. If left untreated, the infection can lead to blindness. Roches’ price for Valganciclovir is Rs 1,040 for a 450mg tablet, or approximately Rs 2,74,560 per patient for a full course of treatment, unaffordable for most people. The decision to set aside the patent is expected to provide much-needed relief as it secures the way for generic competition, which could bring down the price of the drug.
Roche was attempting to patent a new form of a drug that was really invented in the 1980s, said Leena Menghaney, project manager of the MSF Campaign for Access to Essential Medicines in India. This decision shows that Section 3(d) of India’s Patents Act, which prevents companies from obtaining unjustified patents, is working. The patent office also found separately that the patent claims were obvious and therefore not patentable.
Roche was granted the Valganciclovir patent by the Chennai patent office (one of four offices that make up the Indian Patent Office) without hearing the arguments of public interest groups that opposed the granting of the patent.
Setting A Precedent
Wednesday, Mar 22nd
Last update:05:44:44 AM IST